Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL): Quantifying the direct economic costs of post-treatment radiological surveillance.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19574-e19574
Author(s):  
Rachel Louise O'Connell ◽  
Bhupinder Sharma ◽  
Liza Van Kerckhoven ◽  
Aia s Mehdi ◽  
Ayoma Attygalle ◽  
...  
Keyword(s):  
Cell Lymphoma ◽  
Breast Implant ◽  
Large Cell ◽  
Post Treatment ◽  
Economic Costs ◽  
Routine Surveillance ◽  
Imaging Surveillance ◽  
Large Cell Lymphoma ◽  
Routine Imaging

e19574 Background: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) was recognised by the WHO in 2016 as a rare sub-type of peripheral T-cell, non-Hodgkin lymphoma (NHL), characterized by an indolent clinical course and excellent prognosis. Little evidence exists on the role of post-treatment imaging surveillance with variable practices across the world. Recent UK guidelines recommend that routine surveillance imaging should not be offered to BIA-ALCL patients, in line with national/international recommendations for other NHLs. The aim of this study was to quantify the direct economic costs (DEC) of post-treatment BIA-ALCL routine radiological surveillance at our institution compared to the DEC if UK guidelines were followed. Methods: Following IRB approval a retrospective analysis of a prospectively maintained database of BIA-ALCL patients at The Royal Marsden Hospital was performed. DECs were estimated using current (2020) NHS tariffs for radiological investigations. Imaging undertaken for symptomatic problems/non-BIA-ALCL related concerns was excluded. Results: Eleven patients [median age: 49 years (IQR 45-52)] were treated for BIA-ALCL between 2015-2020 following cosmetic augmentation (n = 6) or breast reconstruction (n = 5). Median time from first implant surgery to BIA-ALCL diagnosis was 11 years (IQR 8-12). Patients presented with effusion (n = 7), mass (n = 2) or effusion and mass (n = 2). One patient had neoadjuvant CHOP/brentuximab, all 11 had explantation with en bloc total capsulectomy, 1 had adjuvant CHOP. Median follow-up was 38 months (IQR 12-47) with no local or distant relapses. Two patients did not have any radiological surveillance and 1 had follow-up elsewhere. The remaining 8 patients had a combination of PET/CT (n = 10), CT (n = 2), breast ultrasound (n = 6), mammogram (n = 4) and breast MRI (n = 1) as routine imaging follow-up not guided by clinical concerns. This represents evolving practice at our institution as the UK guidelines were published in 2021. Total cost of routine imaging surveillance was £10,396 ($14,396) with median cost of £1,953 ($2,705) per patient [IQR £526-2029 ($728-2,810)]. This cost could have been saved based on current guidelines recommending no routine surveillance for patients with no symptoms or clinical concerns. Conclusions: This data demonstrates that omission of routine post-treatment imaging surveillance, as per the recent UK guidelines, would result in a median DEC saving of £1,953 ($2,705) per patient at our institution. No local or distant relapses where identified within the follow-up period, in line with the existing literature suggesting BIA-ALCL has a very low risk of relapse and excellent prognosis. These findings provide a value-based analysis to further support the recommendation not to perform routine post-treatment imaging surveillance in patients with BIA-ALCL.

Breast Implant-Associated Anaplastic Large Cell Lymphoma: Treatment Experience In 53 Patients

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 5089-5089 ◽  
Author(s):  
Alexandra Hart ◽  
Mary Jo Lechowicz
Keyword(s):  
Bone Marrow ◽  
Multivariate Analysis ◽  
Cell Lymphoma ◽  
Breast Implant ◽  
Univariate Analysis ◽  
Large Cell ◽  
Increased Risk ◽  
Disease Extension ◽  
Large Cell Lymphoma

Purpose Primary breast lymphomas are exceedingly rare; yet, recent reports continue to describe cases of breast implant-associated anaplastic large cell lymphoma (bi-ALCL). Every year over 250,000 women receive breast implants for cosmetic and reconstructive purposes making it necessary to explore the potential consequences of this emerging disease. Although the majority of cases follow an indolent clinical course, there have been several patient (pt) deaths reported, emphasizing the importance of investigation into variables associated with poor clinical outcomes. The purpose of this study is to describe pts diagnosed with bi-ALCL in order to enhance our management and treatment of this disease. Methods A review of the literature using search engines PubMed and MEDLINE were conducted using search terms “Anaplastic” AND “Lymphoma” AND “Breast,” “ALCL” AND “Breast” AND “Implants,” and “Anaplastic” AND “Breast” AND “Implant.” Articles were analyzed for accurate diagnoses excluding any duplicate pts. Two pts at our institution were reviewed using medical records. Univariate analysis determined significant associations (p<0.05). Multivariate analysis was performed when adequate pt data available. Results Sixty-two pts with bi-ALCL were identified from 29 publications, and two additional pts from our clinical practice were included. Eleven pts were excluded secondary to lack of treatment data. Clinical variables are summarized in Table 1. Twelve pts presented with extracapsular disease. Sixteen of 53 (23.1%) pts presented with a mass. Only nine pts (17%) were adequately staged for NHL. Twenty-one pts received a PET scan, and 9 received a bone marrow biopsy. Twenty one pts (39.6%) received surgery alone, 5 pts (9.4%) received surgery and radiation, 10 pts (18.9%) received surgery and chemotherapy, and 16 pts (30.2%) received surgery, chemotherapy, and radiation, and one pt (1.9%) received chemotherapy alone. CHOP (n=23, 43.4%) was the most common chemotherapy regimen. One pt received a bone marrow transplant (BMT) for upfront consolidative therapy. The median follow up is 15 months (3.6-90 months). Fifteen pts (28.3%) had recurrent disease. Eleven of those 15 pts (73.3%) were treated with salvage chemotherapy. Of those six received CHOP, two received ICE salvage, and three had an autologous BMT. Four patients died from their disease. Univariate analysis demonstrated extracapsular disease extension is associated with increased risk for recurrence (p<.0001) and pt death (p=0.0008). B symptoms at presentation were associated with pt death (p=0.012). Pts presenting with a mass were not at increased odds for recurrence (p=0.36) but were at increased odds for death (p=0.043). Multivariate analysis did not show any significant difference in the odds for recurrence among different treatment modalities. Conclusion This represents the largest series of pts with bi-ALCL described to date. Our analysis confirms extracapsular disease extension is associated with increased risk for recurrence and patient death. Established protocols for NHL staging have not been routinely utilized. More detailed follow-up is necessary for prognostic data in this patient population. Future treatment guidelines will require a multi-disciplinary unified approach. Disclosures: No relevant conflicts of interest to declare.

Risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3,546 women prospectively followed after receiving textured breast implants.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 1565-1565 ◽  
Author(s):  
Paola Ghione ◽  
Peter G. Cordeiro ◽  
Ai Ni ◽  
Qunying Hu ◽  
Nivetha Ganesan ◽  
...  
Keyword(s):  
Breast Reconstruction ◽  
Cell Lymphoma ◽  
Breast Implant ◽  
Breast Implants ◽  
Large Cell ◽  
Long Term Follow Up ◽  
Large Cell Lymphoma ◽  
Prospective Database

1565 Background: Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a rare subtype of T-cell lymphoma, developing in in the fluid or capsule surrounding breast implants, primarily or exclusively in those with textured surfaces. Several prior series have estimated the risk of BIA- ALCL at 1/6920 - 1/3800 women in retrospectively defined cohorts (from diagnosed cases within national or pathology databases), approximating the population at risk from sales records or other estimates (Sirinvasa 2017; Loch-Wilkinson 2017; de Boer 2018). Methods: A prospective cohort study was conducted in the population that underwent breast reconstruction by a single surgeon at Memorial Sloan Kettering Cancer Center (MSKCC) from April 1993 to December 2017. Patients had long-term follow-up, and events related to implants were prospectively recorded. We identified all cases of BIA-ALCL by cross-checking data from internal clinical records, pathology records, and outside reports. Incidence rate per person-years and cumulative incidence when accounting for competing risk were calculated. 134 women who received smooth-surface implants were excluded from the analysis, since these implants have not been associated with BIA-ALCL. Results: From 1993 to 2017, 3546 patients underwent 6023 breast reconstructions using textured surface implants. All reconstructions were performed by a single surgeon (PGC) on patients enrolled in this study. To identify BIA-ALCL occurrence, clinical and pathological data were assessed from a prospective database. Median follow-up was 7 years (range, 3 days - 24.7 years). Eight women developed ALCL after a median exposure of 11.2 years (range, 8.3-15.8 years). Overall risk of BIA-ALCL in this cohort was 0.294 cases per 1000 person-years (1/443 women). Conclusions: This study, evaluating the risk of women with textured breast implants from a prospective database with long-term follow-up, demonstrated that the incidence rate of BIA-ALCL may be higher than previously reported. These results can help inform implant choice for women undergoing breast reconstruction.

scholarly journals Complete Surgical Excision Is Essential for the Management of Patients With Breast Implant–Associated Anaplastic Large-Cell Lymphoma

2016 ◽  
Vol 34 (2) ◽  
pp. 160-168 ◽  
Author(s):  
Mark W. Clemens ◽  
L. Jeffrey Medeiros ◽  
Charles E. Butler ◽  
Kelly K. Hunt ◽  
Michelle A. Fanale ◽  
...  
Keyword(s):  
Anaplastic Large Cell Lymphoma ◽  
Cell Lymphoma ◽  
Breast Implant ◽  
Breast Implants ◽  
Surgical Excision ◽  
Large Cell ◽  
Rare Type ◽  
Complete Surgical Excision ◽  
Large Cell Lymphoma

Purpose Breast implant–associated anaplastic large-cell lymphoma (BI-ALCL) is a rare type of T-cell lymphoma that arises around breast implants. The optimal management of this disease has not been established. The goal of this study is to evaluate the efficacy of different therapies used in patients with BI-ALCL to determine an optimal treatment approach. Patients and Methods In this study, we applied strict criteria to pathologic findings, assessed therapies used, and conducted a clinical follow-up of 87 patients with BI-ALCL, including 50 previously reported in the literature and 37 unreported. A Prentice, Williams, and Peterson model was used to assess the rate of events for each therapeutic intervention. Results The median and mean follow-up times were 45 and 30 months, respectively (range, 3 to 217 months). The median overall survival (OS) time after diagnosis of BI-ALCL was 13 years, and the OS rate was 93% and 89% at 3 and 5 years, respectively. Patients with lymphoma confined by the fibrous capsule surrounding the implant had better event-free survival (EFS) and OS than did patients with lymphoma that had spread beyond the capsule (P = .03). Patients who underwent a complete surgical excision that consisted of total capsulectomy with breast implant removal had better OS (P = .022) and EFS (P = .014) than did patients who received partial capsulectomy, systemic chemotherapy, or radiation therapy. Conclusion Surgical management with complete surgical excision is essential to achieve optimal EFS in patients with BI-ALCL.

scholarly journals Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in Poland: analysis of patient series and practical guidelines for breast surgeons

2020 ◽  
Author(s):  
Piotr Pluta ◽  
Agnieszka Giza ◽  
Małgorzata Kolenda ◽  
Wojciech Fendler ◽  
Marcin Braun ◽  
...  
Keyword(s):  
Anaplastic Large Cell Lymphoma ◽  
Cell Lymphoma ◽  
Breast Implant ◽  
Case Series ◽  
Large Cell ◽  
Series Data ◽  
Treatment Recommendation ◽  
Female Population ◽  
Large Cell Lymphoma

IntroductionAlthough breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is infrequent, with less than 1000 noted cases worldwide, patients consenting for breast implant surgery should be aware of its risk. We describe the first Polish multicenter case-series data on BIA-ALCL patients and present diagnostic and treatment recommendation for breast surgeons.Material and methodsIn cooperation with the Polish Society of Surgical Oncology and Polish Lymphoma Research Group, we collected BIA-ALCL cases in Poland.ResultsWe retrospectively reviewed clinical data of seven BIA-ALCL patients, diagnosed between July 2013 and November 2019. The median time from implant placement to the first BIA-ALCL symptoms was 65 months (range: 33–96 months). All the patients were exposed to textured implants at presentation. Capsulectomy with implant removal was performed in all the patients with immediate reimplantation in 2 cases. In a median follow-up of 19 months (range 5-81 months), there was no recurrence and all the patients stayed alive. Between 2013 and 2019, the incidence of BIA-ALCL in Polish female population age 30 and above ranged from 0 to 0.021/100 000/year.ConclusionsBIA-ALCL is scarce in the Polish population. In a short-term follow-up, patients’ prognosis remains excellent. Due to the withdrawal of roughly textured implants from the market and the exclusion of likely the most potent etiologic factor, it might be expected that the incidence of BIA-ALCL will become even rarer.

scholarly journals Breast implant associated anaplastic large cell lymphoma (BIA-ALCL): a challenging cytological diagnosis with hybrid PET/MRI staging and follow-up

Breast Cancer ◽  
2020 ◽  
Author(s):  
Francesco Verde ◽  
Elena Vigliar ◽  
Valeria Romeo ◽  
Maria Raffaela Campanino ◽  
Antonello Accurso ◽  
...  
Keyword(s):  
Anaplastic Large Cell Lymphoma ◽  
Cell Lymphoma ◽  
Breast Implant ◽  
Large Cell ◽  
Final Diagnosis ◽  
Left Breast ◽  
Imaging Evaluation ◽  
Mri Staging ◽  
Large Cell Lymphoma

Abstract We report a case of a 55-year-old woman with left breast cosmetic augmentation performed 5 years earlier, showing at ultrasound a left small amount of peri-implant effusion suspicious for an anaplastic large cell lymphoma localization. The final diagnosis was obtained by cytology using a small amount of fluid (6 ml). Subsequently, hybrid 18F-FDG PET/MRI was used for pre-operative staging and follow-up. An appropriate management of BIA-ALCL could be obtained even in cases of a small amount of peri-implant effusion, using a comprehensive approach of clinical and imaging evaluation, including PET/MRI as useful and innovative staging imaging technique.

scholarly journals Breast Implant–Associated Anaplastic Large-Cell Lymphoma: Long-Term Follow-Up of 60 Patients

2014 ◽  
Vol 32 (2) ◽  
pp. 114-120 ◽  
Author(s):  
Roberto N. Miranda ◽  
Tariq N. Aladily ◽  
H. Miles Prince ◽  
Rashmi Kanagal-Shamanna ◽  
Daphne de Jong ◽  
...  
Keyword(s):  
Complete Remission ◽  
Anaplastic Large Cell Lymphoma ◽  
Cell Lymphoma ◽  
Breast Implant ◽  
Large Cell ◽  
Implant Removal ◽  
Fibrous Capsule ◽  
Large Cell Lymphoma

Purpose Breast implant–associated anaplastic large-cell lymphoma (ALCL) is a recently described clinicopathologic entity that usually presents as an effusion-associated fibrous capsule surrounding an implant. Less frequently, it presents as a mass. The natural history of this disease and long-term outcomes are unknown. Patients and Methods We reviewed the literature for all published cases of breast implant–associated ALCL from 1997 to December 2012 and contacted corresponding authors to update clinical follow-up. Results The median overall survival (OS) for 60 patients was 12 years (median follow-up, 2 years; range, 0-14 years). Capsulectomy and implant removal was performed on 56 of 60 patients (93%). Therapeutic data were available for 55 patients: 39 patients (78%) received systemic chemotherapy, and of the 16 patients (28%) who did not receive chemotherapy, 12 patients opted for watchful waiting and four patients received radiation therapy alone. Thirty-nine (93%) of 42 patients with disease confined by the fibrous capsule achieved complete remission, compared with complete remission in 13 (72%) of 18 patients with a tumor mass. Patients with a breast mass had worse OS and progression-free survival (PFS; P = .052 and P = .03, respectively). The OS or PFS were similar between patients who received and did not receive chemotherapy (P = .44 and P = .28, respectively). Conclusion Most patients with breast implant–associated ALCL who had disease confined within the fibrous capsule achieved complete remission. Proper management for these patients may be limited to capsulectomy and implant removal. Patients who present with a mass have a more aggressive clinical course that may be fatal, justifying cytotoxic chemotherapy in addition to removal of implants.

scholarly journals Breast Implant-Associated Anaplastic Large Cell Lymphoma: A Cost Evaluation Study of Management and Surveillance, and Review of the Recent USA and UK Guidelines

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4014-4014
Author(s):  
Aia S Mehdi ◽  
Rachel O'Connell ◽  
Michael Potter ◽  
Chris Marshall ◽  
Liza Van Kerckhoven ◽  
...  
Keyword(s):  
Health Care ◽  
Board Of Directors ◽  
Research Funding ◽  
Cell Lymphoma ◽  
Breast Implant ◽  
Large Cell ◽  
Post Treatment ◽  
Advisory Committees ◽  
Surveillance Imaging

Abstract Introduction Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a T-cell lymphoma associated with textured breast implants, recently recognized by the revised WHO Classification. Recommended management for BIA-ALCL involves a multidisciplinary team (MDT) approach with breast surgery, haemato-oncology, pathology, radiology and oncoplastic input. Definitive management for the 'effusion-only' subset is surgical implant and capsule removal; systemic therapy is reserved for 'mass-forming' and 'advanced-disease' cohorts. Overall prognosis is excellent with the vast majority achieving remission. Although the diagnostic and treatment paradigm is established, post treatment surveillance and follow-up guidance varies widely (globally); over-utilisation of imaging tests compromises the patient pathway, impacts limited health-care resources and is associated financial burdens on patients and providers. Recently, newly published consensus guidelines (UK MHRA and USA NCCN clarify follow-up and surveillance imaging (Table 1). The aim of this study was to review our BIA-ALCL specialist centre institutional practise; to quantify the direct economic cost (EC) of imaging surveillance and indirect EC of outpatient clinic (OPC) assessment compared EC if recent guidelines were followed. The secondary aim is to highlight and raise awareness of the latest international guidance to promote the standardisation of practise. Methods A retrospective analysis of a prospectively maintained patient database between July 2015 to October 2019 was conducted, with Institutional Review Board Approval. Data collection included patient demographics, tumour subset, treatment, clinical and imaging surveillance. Follow-up and imaging undertaken for symptomatic concerns / non-BIA-ALCL related pathology was excluded. Imaging costs were calculated using UK NHS tariffs. Results Eleven patients were treated for BIA-ALCL during the study period, with a median age of 49 at diagnosis (range 30-82years). Patients were diagnosed with: effusion-only (n=7), effusion and mass (n=2), mass-only (n=2) subtypes, at a median time of eleven years from implant insertion (IQR 8-12). All patients underwent explantation and en-bloc capsulectomy, with 1 patient required neo-adjuvant (CHOP, Brentuximab) and 1 adjuvant (CHOP) therapy (CHOP. Surveillance with imaging and OPC detected no disease recurrence to date (overall median follow-up 38 months, IQR 12-47). Post treatment episodes of surveillance imaging or follow-up related to patient symptoms were excluded. 8 patients underwent surveillance imaging at our institute (Table 2). Total cost of imaging was £10,396 ($14,396) with a median cost of £1,953 ($2,705) per patient [IQR £526-2029 ($728-2,810)]. 7 patients had completed at least 24 months follow-up since surgery during the study period (Table 3), with 3 patients having not yet completed their follow-up period of two years. Of those with completed follow-up, the median OPC follow-up per patient was 48 months (IQR 38-52), median number of OPC was 7 (IQR 6-11) and the median cost of clinic review was £982 (IQR 804-1395). The surplus cost per patient compared with recommended follow-up was £118 ($164) [IQR £0-531 ($0-738)]. Conclusions Our data shows the variable BIA-ALCL surveillance practise pattern and the associated additional direct and indirect EC of unnecessary asymptomatic surveillance imaging, with an excessive number of follow-up OPC and period of clinical follow-up after complete remission. With no recurrence detected in our patient cohort to date, this data supports the new UK and updated USA NCCN Guidelines (extrapolated from data in other NHLs, and analogous to principles of the ASH Choosing Wisely Campaign) that routine post-treatment surveillance imaging should not be performed in BIA-ALCL patients. Routine asymptomatic post-treatment surveillance imaging is clinically unnecessary and potentially leads to a 'Cascade Effect' of further tests, with increased radiation exposure, excess costs and impact on limited health-care resources. We also support open-access follow-up for patients in remission, to reduce unnecessary follow up appointments. With UK and USA guidelines now available for BIA-ALCL, we support training and education of health-care professionals, global consensus guidelines and a registry, for this rare however increasingly recognised new entity. Figure 1 Figure 1. Disclosures Iyengar: Takeda: Membership on an entity's Board of Directors or advisory committees, Other: conference support, Speakers Bureau; Gilead: Membership on an entity's Board of Directors or advisory committees, Other: conference support, Speakers Bureau; Beigene: Membership on an entity's Board of Directors or advisory committees; Abbvie: Other: conference support; Janssen: Other: conference support, Speakers Bureau. Nicholson: Pfizer: Consultancy; Kite, a Gilead Company: Other: Conference fees, Speakers Bureau; BMS/Celgene: Consultancy; Novartis: Consultancy, Other: Conference fees. El-Sharkawi: Kyowa Kirin: Other: Ad boards; Beigene: Other: Ad boards; ASTEX: Other: Ad boards; Novartis: Other: Travel Support; Takeda: Honoraria; Roche: Honoraria; Janssen: Honoraria, Other: Ad boards; AstraZeneca: Honoraria, Other: Ad boards; AbbVie: Honoraria, Other: Travel Support, Ad boards. Tasoulis: BMJ: Consultancy, Membership on an entity's Board of Directors or advisory committees. Cunningham: Roche: Research Funding; Clovis Oncology: Research Funding; Celgene: Research Funding; Eli Lilly: Research Funding; Bayer: Research Funding; OVIBIO: Membership on an entity's Board of Directors or advisory committees; 4SC: Research Funding; AstraZeneca: Research Funding; MedImmune: Research Funding.

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